Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

NCT00906997 | Completed DMC

• 1 other identifier: COLONPREV
• Study Type: interventional
• Target: 55,498
• Locations: 1 country
• Sites: 8

Brief Summary

Aims:

• Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
• Group II: colonoscopy. Sample-size calculation: 27,749 subjects in each study group (total: 55,498).

Conditions

Colorectal Cancer; Colorectal Neoplasm

Keywords

Colorectal cancer; Screening; Prevention; Fecal occult blood test; Colonoscopy; Colorectal neoplasm; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer-related mortality

  10 years

Secondary Outcomes (5)

• Compliance rate

  2 years

• Complication rate

  10 years

• Colorectal cancer incidence

  15 years

• Adherence rate

  10 years

• Advanced colorectal neoplasm detection rate

  2 years

Study Arms (2)

Fecal occult blood testing

ACTIVE COMPARATOR

Fecal immunochemical testing biennially

Procedure: Immunochemical fecal occult blood test

Colonoscopy

ACTIVE COMPARATOR

Colonoscopy one time

Procedure: Colonoscopy

Interventions

Immunochemical fecal occult blood test PROCEDURE

Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.

Fecal occult blood testing

Colonoscopy PROCEDURE

Every 10 years, with sedation.

Colonoscopy

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 50-69 years

You may not qualify if:

• Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
• Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)
• Severe comorbidity
• Previous total colectomy
• Not signed informed consent to participate

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundacion Cientifica de la Asociacion Española contra el Cancer: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (8)

Hospital del Mar

Barcelona, Spain

Location

Hospital Clínico

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Meixoeiro

Ourense, Spain

Location

Hospital de Donosti

San Sebastián, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Comunidad Valencia

Valencia, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Spain

Location

Related Publications (7)

• Castells A, Quintero E, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazan R, Alonso-Abreu I, Banales JM, Hernandez V, Portillo I, Vanaclocha-Espi M, de la Vega M; COLONPREV study investigators. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025 Apr 12;405(10486):1231-1239. doi: 10.1016/S0140-6736(25)00145-X. Epub 2025 Mar 27.

  PMID: 40158525 DERIVED

• Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122.

  PMID: 33657038 DERIVED

• Salas D, Vanaclocha M, Ibanez J, Molina-Barcelo A, Hernandez V, Cubiella J, Zubizarreta R, Andreu M, Hernandez C, Perez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentin V, Lanas A, Quintero E, Castells A. Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening. Cancer Causes Control. 2014 Aug;25(8):985-97. doi: 10.1007/s10552-014-0398-y. Epub 2014 May 24.

  PMID: 24859111 DERIVED

• Castells A, Quintero E, Alvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernandez C, Jover R, Hijona E, Portillo I, Enriquez-Navascues JM, Hernandez V, Martinez-Turnes A, Menendez-Villalva C, Gonzalez-Mao C, Sala T, Ponce M, Andres M, Teruel G, Peris A, Sopena F, Gonzalez-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo A, Pellise M, Balaguer F, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrandiz J, Gonzalez-Hernandez MJ, Andreu M, Bessa X; COLONPREV Study Investigators. Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests. Clin Gastroenterol Hepatol. 2014 Oct;12(10):1708-16.e4. doi: 10.1016/j.cgh.2014.03.022. Epub 2014 Mar 27.

  PMID: 24681078 DERIVED

• Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.

  PMID: 24574776 DERIVED

• Bujanda L, Lanas A, Quintero E, Castells A, Sarasqueta C, Cubiella J, Hernandez V, Morillas JD, Perez-Fernandez T, Salas D, Andreu M, Carballo F, Bessa X, Cosme A, Jover R; COLONPREV Study Investigators. Effect of aspirin and antiplatelet drugs on the outcome of the fecal immunochemical test. Mayo Clin Proc. 2013 Jul;88(7):683-9. doi: 10.1016/j.mayocp.2013.04.016. Epub 2013 Jun 7.

  PMID: 23751980 DERIVED

• Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.

  PMID: 22356323 DERIVED

Related Links

• Webpage of the Spanish Gastroenterological Association, which endorses COLONPREV trial

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Antoni Castells, MD

  Hospital Clínic, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Enrique Quintero, MD

  Hospital Universitario de Canarias, Tenerife, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: November 1, 2008
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

ES (8)